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Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.
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This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROP/KET/CLON/EPI/SAL | Experimental | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml |
|
| Placebo | Placebo Comparator | 0.9% Sodium Chloride- 100ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivacaine (5mg/ml)-50ml |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Universal Pain Assessment Tool (UPAT) | Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery. | 3 days after surgery |
| Narcotic Use During Hospitalization | The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine. | 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Subjective Rating of Pain | Patients are asked if their pain is acceptable (yes/no) | 3 days after surgery |
| UPAT Score Before and After Physical Therapy | Pain in score change after physical therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Golladay, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ROP/KET/CLON/EPI/SAL | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
| FG001 | Placebo | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ROP/KET/CLON/EPI/SAL | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Universal Pain Assessment Tool (UPAT) | Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery. | Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported | Posted | 3 days after surgery |
|
48 hours post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ROP/KET/CLON/EPI/SAL | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Potter | Virginia Commonwealth University | 804-828-6749 | teresa.potter@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2015 | Mar 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020910 | Ketorolac |
| D003000 | Clonidine |
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ketorolac | Drug | ketorolac (30mg/ml)- 1 ml |
|
|
| Clonidine | Drug | clonidine (0.1mg/ml)- 0.8ml |
|
|
| Epinephrine | Drug | epinephrine (1mg/ml)-1ml |
|
|
| 0.9% sodium chloride | Drug | Sodium chloride 0.9%- 47.7 ml |
|
|
| 3 days after surgery |
| Ambulation During Physical Therapy | The length (in feet) patient is able to ambulate during physical therapy | 48 hours after surgery |
| BG001 | Placebo | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
|
| Primary | Narcotic Use During Hospitalization | The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine. | Posted | Mean | Standard Deviation | mg morphine equivalents | 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period |
|
|
|
| Secondary | Patient's Subjective Rating of Pain | Patients are asked if their pain is acceptable (yes/no) | Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported | Posted | 3 days after surgery |
|
|
| Secondary | UPAT Score Before and After Physical Therapy | Pain in score change after physical therapy | Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported | Posted | 3 days after surgery |
|
|
| Secondary | Ambulation During Physical Therapy | The length (in feet) patient is able to ambulate during physical therapy | Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported | Posted | 48 hours after surgery |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Placebo | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Full 48 hour post surgery period |
|